Eligible Trials and Studies
Eligible trial types for BIQSFP funding are:
- Trials conducted by CG's and CCOP Research Bases.
- Phase 3 treatment trials with integral or integrated biomarker or imaging studies, and/or quality of life studies.
- Phase 3 cancer prevention and QOL clinical trials with integral or integrated biomarker or imaging studies, and/or QOL studies.
- Large (≥100 patients), randomized phase 2 treatment trials with integral or integrated biomarker or imaging studies.
- For CEA, the parent concept must be a randomized phase 3 clinical trial with a comparator arm.
Treatment Trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer. The treatments tested may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques, and vaccines or other treatments that stimulate a person's immune system to fight cancer. Combinations of different treatment types may also be tested in these trials.1
Cancer Prevention Trials test new interventions that may lower the risk of developing certain types of cancer. Most cancer prevention trials involve healthy people who have not had cancer; however, they often only include people who have a higher than average risk of developing a specific type of cancer. Some cancer prevention trials involve people who have had cancer in the past; these trials test interventions that may help prevent the return (recurrence) of the original cancer or reduce the chance of developing a new type of cancer.1
Quality-of-Life (Supportive Care) Trials focus on the comfort and quality of life of cancer patients and cancer survivors. New ways to decrease the number or severity of side effects of cancer or its treatment are often studied in these trials. How a specific type of cancer or its treatment affects a person's everyday life may also be studied.1
Treatment trials are submitted to CTEP for evaluation by the appropriate NCI Disease-Specific Scientific Steering Committee.
Cancer prevention and QOL trials are submitted to DCP for evaluation by the appropriate NCI Scientific Steering Committee.
Two types of Essential Biomarker, Imaging, and Quality of Life studies are eligible:
Integral studies – Defined as tests that must be performed in order for the trial to proceed. Integral studies are inherent to the design of the trial from the onset and must be performed in real time for the conduct of the trial. Integral biomarkers require a CLIA-certified lab.
Integral studies have the highest funding priority.
Eligible categories of integral studies and examples are as follows:
- Tests to establish eligibility – e.g., ERCC-1 to determine protocol eligibility for patients with gastric cancer or imaging assessment of hypoxia for trials of drugs effective in hypoxic tissues such as tirapazamine
- Tests for patient stratification – e.g., measurement of 18qLOH and MSI for assignment of risk in stage 2 colon cancer
- Tests to assign patients to a treatment arm of a trial, including surrogate endpoints for assignment of treatment during a trial – e.g., FLT3/ITD ratio for assignment of pediatric AML patients to a study arm; eradication of the bcr-abl clone in CML to determine whether to continue treatment; FDG-PET scan after initial course of therapy to assess early response to determine whether to continue treatment where third-party payers would not cover the cost
- Non-reimbursable imaging tests to measure a primary endpoint or to stratify patients based on imaging response – e.g. PET scans for non-Hodgkin's lymphoma response to chemotherapy
Integrated Studies – Defined as tests that are clearly identified as part of the clinical trial from the beginning and are intended to identify or validate assays or markers and imaging tests that are planned for use in future trials. Integrated studies in general should be designed to test a hypothesis, not simply to generate hypotheses. Integrated studies are tests performed on patients during the trial and include complete plans for specimen collection, laboratory measurements, proposed cutpoints, and statistical analysis. One example would be predictive marker assays that are measured either in vitro or in vivo on all cases but where the assay result is not used for eligibility, treatment assignment, or treatment management in the current trial; a second example would be the use of an imaging test to detect biologic modification of the target but where the image is not used as a primary study endpoint.
Exceptions
While the primary purpose of this funding is for newly developed concepts, in some circumstances, large randomized phase 2 and any phase 3 protocols with an integral or integrated component, and/or cancer prevention or QOL protocols that are still in development may be considered for the BIQSFP if they are of exceptional clinical importance and address the evaluation criteria and Performance Standards. It is recommended that these be discussed with CTEP or DCP Program Staff prior to submission to determine eligibility. In general, the priority for consideration in these circumstances would be for studies requiring integral markers.
